An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.

Acronym

A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.

Scientific Title

An exploratory study of the efficacy and safety of yokukansan for postoperative delirium in patients who underwent surgical resection of malignant tumor of digestive system.

Scientific Title:Acronym

A clinical study of yokukansan in patients with postoperative delirium after surgical resection of malignant tumor of digestive system.

Region

Japan

Condition

Condition

Digestive system cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Objectives

Narrative objectives1

To investigate the inhibition effect and safety of yokukansan for onset of postoperative delirium in elderly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Incidence of postoperative delirium

Key secondary outcomes

Postoperative length of stay in the hospital
Severity of symptoms of delirium
Safety

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Numbered container method

Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

yokukansan administering group(7.5mg/day)

Interventions/Control_2

yokukansan non-administering group (0mg/day)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who scheduled surgical resection of malignant tumor of digestive system.
2) Patients who can be administered drugs orally.
3) Patients who give written informed consent to participate in the study

Key exclusion criteria

1) Patients who require emergency surgery.
2)Patients with severe complications, including cardiac, renal, blood or lung diseases, or with other complications judged to be life-threatening.
3)Patients administered antipsychotic agents and therapeutic agents for dementia.
4)Patients administered Kampo medicines other than the study drug.
5) Patients who were judged to be inappropriate as subjects by the study investigators